Manager, Quality Engineering Commissioning & Qualification

Manager, Quality Engineering Commissioning & Qualification
 

Reporting into the Leader, Quality Engineering Commissioning & Qualification the Manager, Quality Engineering Commissioning & Qualification will be responsible for Quality oversight of GMP-compliant commissioning and qualification of facilities and equipment. The individual will be accountable for process and product quality of commercial products and of Capex projects of a manufacturing site.

• The incumbent will have demonstrated strong technical knowledge in the one or more areas of commissioning, qualification, and cGMP compliance. They will support QA oversight of quality standards and systems aligned with the Engineering function in the above areas. They will be experienced in associated regulatory inspections

• This role will be responsible for activities in one or more of the following areas:  all transfers to commercial, internal & external: Commissioning & Qualification, , Commissioning, Qualification, System Verification/commissioning, URS, Risk analysis, IQ/OQ/PQ, Requalification, SOP’s review & approval, Deviation (oversight), Changes, Inspections

• The incumbent will foster industry best practices and implement into site processes

The incumbent will work with the teams within of Global Engineering

The incumbent will work closely with his or her peers in Quality Engineering from the other manufacturing sites and ensure that the same principles and systems are applied across all CSL Behring manufacturing sites and that in all projects the appearance of the documentation in the stated areas is standardized.

The position requires the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organization.

Conduct Quality Assurance Oversight activities including issue and Risk Management for local capital investment projects in area of responsibility (Commissioning & Qualification).

• Collaborate with internal partners for the execution of all capital projects – EU, AUS and US and others – to deliver projects on time and to the required standards and regulatory requirements.

• Delivers a consistent quality approach to facility and process design and development for capital projects

• Provide QA oversight on process within capital project.

Conduct Quality Assurance Oversight activities including issue and Risk Management, for Commissioning & Qualification

• Collaborate with peers in Engineering across manufacturing sites with internal partners for the execution of commissioning and qualification activities to deliver these changes on time and to the required standards.

• Supports Quality decisions regarding C&Q activities are aligned with the direction of the organization.

• Supports risks assessments and ensures up-to-date information

• Supports definition of requalification cycles and requirements for maintenance activities

• Supports Process Engineering and Sites in improvements projects and provides QA guidance

Conduct Quality Assurance Oversight activities for Engineering Standards & Engineering Documentation and Knowledge Management in Commissioning & Qualification

• Delivers to global engineering standards and processes consistent with regulatory requirements and industry standards (quality systems, policies, procedures, and work instructions).

• Provides input to engineering on the content of an appropriate Documentation and Knowledge Management system for the Engineering function.

• Responsible for the approval of the documentation in the above areas, ensure compliance to GMP and that required standards are met. Ensure a harmonized appearance of all documentation across the entire capital project.

• Delivers against global standards for commissioning and qualification

• Participate in deviations, SQUIPP assessment, ensure compliance of the final deviation reports.

• Facilitate global and local change controls

Qualifications:

• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 5+ years' GMP experience in pharmaceutical/biotech/or other regulated industry
• Experience within a global matrix organization
• Knowledge of current Good Manufacturing Practices (cGMP) principles
• Knowledge of appropriate regulatory requirements

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.